The Agency'sCommitteefor MedicinalProducts for HumanUse (CHMP) has concluded thatpiroxicam'sbenefitsstilloutweighitsrisks, but, based onsafety grounds, only in certain, limitedindications.
The CommitteeforMedicinalProductsforHumanUse(CHMP) of the European Medicines Agency today recommended that mipomersen (Kynamro, Isis and Genzyme) not be approved foruse in Europe.
The FDA action follows a similar decision by the CommitteeforMedicinalProductsforHumanUse(CHMP) of the European Medicines Agency, which announced last week that it had recommended that Pradaxa be contraindicated in patients with prosthetic heart valves.